Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types

Condition(s) studied

Investigational drug(s) / intervention(s)

Medial Stabilized Insert: A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.

Cruciate Retaining Insert: A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.

Study summary

This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.

Eligibility

Primary outcome measure(s)

• Forgotten Joint Score (FJS) — Pre-operative, 6 weeks, 6 months, and 2 years post-operatively
  Forgotten Joint Score (FJS) The Forgotten Joint Score (FJS) is a patient-reported outcome measure assessing joint awareness in daily life following total knee arthroplasty. The score ranges from 0 to 100, with higher scores indicating better outcomes (less joint awareness).

Trial sites (1)

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